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Effects of lower extremity robotic training on response of brain regions and neuromuscular function in stroke patients

Characteristics of corticomuscular coupling during lower extremity robotics for lower limb function after stroke

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500099273
Enrollment
Unknown
Registered
2025-03-20
Start date
2025-04-01
Completion date
Unknown
Last updated
2025-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Interventions

Study 1: Cross-sectional study, healthy subjects:All healthy subjects were subjected to fNIRS, surface electromyography, and gait data collection in order under various conditions. The fNIRS optical i
Study 2: Intervention Study, Control Group:The control group received routine medication and rehabilitation treatment for 60 minutes. Treat continuously for 3 weeks, 5 times a week.
Study 2: Intervention Study, Experimental Group:The experimental group received lower limb robot training for 60 minutes each time on the basis of the control group. Treat continuously for 3 weeks, 5
Study 1: Cross-sectional study, stroke patients:All stroke patients were subjected to fNIRS, surface electromyography, and gait data collection in order under various conditions. The fNIRS optical ima

Sponsors

The First Rehabilitation Hospital of Shanghai
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Study 1: Inclusion criteria for stroke patients: 1. The subject suffered from unilateral limb paralysis due to the first clinical stroke, with a duration of less than 12 months; 2. The subjects are aged between 18 and 75 years old; 3. Weight= 24 on the Mini Mental State Examination (MMSE); 6. Agree and sign the informed consent form for this clinical study. Inclusion criteria for healthy subjects: 1. Normal vision or corrected to normal; 2. Age between 18 and 75 years old; 3. No gait disorders and no limb injuries; Study 2: Inclusion criteria for stroke patients: 1. The subject suffered from unilateral limb paralysis due to the first clinical stroke, with a duration of less than 12 months; 2. The subjects are aged between 18 and 75 years old; 3. Weight= 24 on the Mini Mental State Examination (MMSE); 6. Agree and sign the informed consent form for this clinical study.

Exclusion criteria

Exclusion criteria: Study 1: Exclusion criteria for stroke patients: 1. Unstable basic vital signs; 2. Lower limb bone and joint tumors, deformities, and lower limb amputations; 3. Severe spinal deformities; 4. Severe osteoporosis; 5. New York College of Cardiology heart function classification >= Grade III; 6. Limited range of motion of lower limb joints and deep vein thrombosis in lower limbs; 7. Serious musculoskeletal disorders that affect lower limb motor function, such as severe persistent joint stiffness; 8. Lower limb fractures do not meet clinical healing standards; 9. Severe spasticity of the lower limbs (modified Ashworth >= 3 grade). Exclusion criteria for healthy subjects: 1. Existence of any neurological or physical illnesses; 2. History of any psychological or psychiatric disorders; 3. Lower limb fractures and surgical history; 4. Subjects who have experienced robot assisted gait. Study 2: Exclusion criteria for stroke patients: 1. Unstable basic vital signs; 2. Lower limb bone and joint tumors, deformities, and lower limb amputations; 3. Severe spinal deformities; 4. Severe osteoporosis; 5. New York College of Cardiology heart function classification >= Grade III; 6. Limited range of motion of lower limb joints and deep vein thrombosis in lower limbs; 7. Serious musculoskeletal disorders that affect lower limb motor function, such as severe persistent joint stiffness; 8. Lower limb fractures do not meet clinical healing standards; 9. Severe spasticity of the lower limbs (modified Ashworth >= 3 grade).

Design outcomes

Primary

MeasureTime frame
Fugl-Meyer Scale scores;

Secondary

MeasureTime frame
10 Meter Walk Test scores;Functional Ambulation Category scores;Berg’s Balance Scale scores;6 Minute Walk Test scores;Functional near-infrared spectroscopy outcomes;Surface electromyography outcomes;Three-dimensional motion analysis outcomes;

Countries

China

Contacts

Public ContactWu Xuejiao

The First Rehabilitation Hospital of Shanghai

wxj11j@163.com+86 21 6543 2021

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026